Bromocriptine Mesylate Capsules 5mg (Zydus) – Impurity Specifications (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Brand
Zydus Pharmaceuticals USA Inc
Lot Codes / Batch Numbers
Lot # MP993, Exp10/16, MR2704, Exp 02/17, MR6851, MR8100, Exp 07/17 and MR1210, Exp 12/17
Products Sold
Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17
Zydus Pharmaceuticals USA Inc is recalling Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Health due to Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (2. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026